1.Construction of core outcome set for clinical research on traditional Chinese medicine treatment of simple obesity.
Tong-Tong WU ; Yan YU ; Qian HUANG ; Xue-Yin CHEN ; Fu-Ming-Xiang LIU ; Li-Hong YANG ; Chang-Cai XIE ; Shao-Nan LIU ; Yu CHEN ; Xin-Feng GUO
China Journal of Chinese Materia Medica 2025;50(12):3423-3430
Following the core outcome set standards for development(COS-STAD), this study aims to construct core outcome set(COS) for clinical research on traditional Chinese medicine(TCM) treatment of simple obesity. Firstly, a comprehensive review was conducted on the randomized controlled trial(RCT) and systematic review(SR) about TCM treatment of simple obesity that were published in Chinese and English databases to collect reported outcomes. Additional outcomes were obtained through semi-structured interviews with patients and open-ended questionnaire surveys for clinicians. All the collected outcomes were then merged and organized as an initial outcome pool, and then a preliminary list of outcomes was formed after discussion by the working group. Subsequently, two rounds of Delphi surveys were conducted with clinicians, methodology experts, and patients to score the importance of outcomes in the list. Finally, a consensus meeting was held to establish the COS for clinical research on TCM treatment of simple obesity. A total of 221 RCTs and 12 SRs were included, and after integration of supplementary outcomes, an initial outcome pool of 141 outcomes were formed. Following discussions in the steering advisory group meeting, a preliminary list of 33 outcomes was finalized, encompassing 9 domains. Through two rounds of Delphi surveys and a consensus meeting, the final COS for clinical research on TCM treatment of simple obesity was determined to include 8 outcomes: TCM symptom scores, body mass index(BMI), waist-hip ratio, waist circumference, visceral fat index, body fat rate, quality of life, and safety, which were classified into 4 domains: TCM-related outcomes, anthropometric measurements, quality of life, and safety. This study has preliminarily established a COS for clinical research on TCM treatment of simple obesity. It helps reduce the heterogeneity in the selection and reporting of outcomes in similar clinical studies, thereby improving the comparability of research results and the feasibility of meta-analysis and providing higher-level evidence support for clinical practice.
Humans
;
Obesity/therapy*
;
Medicine, Chinese Traditional
;
Randomized Controlled Trials as Topic
;
Treatment Outcome
;
Drugs, Chinese Herbal/therapeutic use*
2.Study on the selection preferences for the community health management service model of older patients with multiple chronic diseases
Xuan-xuan WANG ; Si-yu CAI ; Gang WANG ; Shao-fan CHEN ; Dong-fu QIAN
Chinese Journal of Health Policy 2025;18(3):32-40
Objective:This study was aimed to explore the preference and heterogeneity in community health management service model selection among older patients with multiple chronic diseases,and to provide scientific evidence for optimizing the model.Methods:A multi-stage stratified and convenience sampling approach was adopted.A discrete choice experiment was conducted with 360 elderly patients with multiple chronic diseases from six regions in Jiangsu Province.The Mixed Logit Model was used to analyze service selection preferences and willingness to pay,while the Latent Class Logit Model was applied to explore heterogeneity among patient groups.Results:Patients showed a stronger preference for a service model featuring"twice-monthly visits,medication guidance+lifestyle counseling,and face-to-face consultations,"with willingness to pay values of 170.18 CNY,162.90 CNY,and 112.70 CNY,respectively.Willingness to pay decreased as out-of-pocket costs increased.Heterogeneity analysis identified three distinct preference groups,with statistically significant differences in urban-rural distribution,income levels,and health insurance types.Conclusions and suggestions:Medication and lifestyle guidance are the most valued components of community health management services among older patients with multiple chronic diseases.Patients'demographic and socioeconomic characteristics have a structural influence on their service preferences,highlighting the need to tailor service provision to different population groups.It is recommended to enhance medication guidance capacity at the primary care level,especially in rural areas;promote physical medicine integration to improve the accuracy and effectiveness of lifestyle guidance provided by primary healthcare personnel;strengthen digital infrastructure and streamline service processes to moderately increase the frequency of face-to-face consultations;and improve the integration of medical insurance and public health funding mechanisms to enhance service accessibility and equity.
3.Analysis of clinical phenotypes and genotypic characteristics in children with epilepsy
Yanli JIANG ; Lulu YAN ; Bin FU ; Dongli CAI ; Min XIE ; Xinhua SHAO ; Changshui CHEN ; Shanshan WU ; Haibo LI
Chinese Journal of Medical Genetics 2025;42(9):1045-1052
Objective:To investigate the clinical phenotypes and genetic variant characteristics in children with epilepsy.Methods:A total of 91 children with epilepsy admitted to the Women′s and Children′s Hospital Affiliated to Ningbo University from July 2021 to October 2022 were selected as the study subjects. Peripheral blood samples were collected from the children for whole exome sequencing. Candidate genetic variants were validated by Sanger sequencing and copy number variation sequencing (CNV-seq). The clinical phenotypes and treatment outcomes of the children with epilepsy were followed up, and an analysis of the relationship between genotype and phenotype was conducted. This study was approved by the Women′s and Children′s Hospital Affiliated to Ningbo University (Ethics No.: EC2020-048).Results:Among the 91 children with epilepsy, 21 cases (23.08%, 21/91) were found to carry pathogenic or likely pathogenic variants. Of these, 18 cases had involved single base variant or insertional deletion, while 3 cases involved copy number variations. The gene with the highest detection rate was PRRT2 (38.10%, 8/21). Among the children with genetic variants, 47.62% (10/21) had onset during infancy, with 8 diagnosed with Benign familial infantile epilepsy (BFIE), 8 with Developmental epileptic encephalopathy (DEE), and 3 with Epileptic encephalopathy (EE). One case of Dravet syndrome (DS) and one case of Infantile spasms (IS) were also noted. The clinical manifestations of children were diverse and primarily included generalized tonic-clonic seizures and focal seizures. Among them, 52.38% (11/21) had exhibited cluster seizures, 23.81% (5/21) showed fever sensitivity, and 14.29% (3/21) experienced status epilepticus. After pharmacological treatment, 42.86% (9/21) of children had achieved complete seizure control, while 61.90% (13/21) had intellectual disability and 19.05% (4/21) had co-morbid autism spectrum disorder. Conclusion:Pathogenic or likely pathogenic variants were identified in 23.08% of the pediatric epilepsy cases, with the PRRT2 gene being the most frequently involved. Among children carrying genetic variants, 47.62% had seizure onset during infancy. Genetic factors are an important cause of epilepsy, and early genetic testing may facilitate precise diagnosis, treatment, and prognostic evaluation.
4.Analysis of clinical phenotypes and genotypic characteristics in children with epilepsy.
Yanli JIANG ; Lulu YAN ; Bin FU ; Dongli CAI ; Min XIE ; Xinhua SHAO ; Changshui CHEN ; Shanshan WU ; Haibo LI
Chinese Journal of Medical Genetics 2025;42(9):1045-1052
OBJECTIVE:
To investigate the clinical phenotypes and genetic variant characteristics in children with epilepsy.
METHODS:
A total of 91 children with epilepsy admitted to the Women's and Children's Hospital Affiliated to Ningbo University from July 2021 to October 2022 were selected as the study subjects. Peripheral blood samples were collected from the children for whole exome sequencing. Candidate genetic variants were validated by Sanger sequencing and copy number variation sequencing (CNV-seq). The clinical phenotypes and treatment outcomes of the children with epilepsy were followed up, and an analysis of the relationship between genotype and phenotype was conducted. This study was approved by the Women's and Children's Hospital Affiliated to Ningbo University (Ethics No.: EC2020-048).
RESULTS:
Among the 91 children with epilepsy, 21 cases (23.08%, 21/91) were found to carry pathogenic or likely pathogenic variants. Of these, 18 cases had involved single base variant or insertional deletion, while 3 cases involved copy number variations. The gene with the highest detection rate was PRRT2 (38.10%, 8/21). Among the children with genetic variants, 47.62% (10/21) had onset during infancy, with 8 diagnosed with Benign familial infantile epilepsy (BFIE), 8 with Developmental epileptic encephalopathy (DEE), and 3 with Epileptic encephalopathy (EE). One case of Dravet syndrome (DS) and one case of Infantile spasms (IS) were also noted. The clinical manifestations of children were diverse and primarily included generalized tonic-clonic seizures and focal seizures. Among them, 52.38% (11/21) had exhibited cluster seizures, 23.81% (5/21) showed fever sensitivity, and 14.29% (3/21) experienced status epilepticus. After pharmacological treatment, 42.86% (9/21) of children had achieved complete seizure control, while 61.90% (13/21) had intellectual disability and 19.05% (4/21) had co-morbid autism spectrum disorder.
CONCLUSION
Pathogenic or likely pathogenic variants were identified in 23.08% of the pediatric epilepsy cases, with the PRRT2 gene being the most frequently involved. Among children carrying genetic variants, 47.62% had seizure onset during infancy. Genetic factors are an important cause of epilepsy, and early genetic testing may facilitate precise diagnosis, treatment, and prognostic evaluation.
Humans
;
Female
;
Male
;
Epilepsy/genetics*
;
Child, Preschool
;
Child
;
Phenotype
;
Genotype
;
DNA Copy Number Variations/genetics*
;
Infant
;
Membrane Proteins/genetics*
;
Nerve Tissue Proteins/genetics*
;
Adolescent
;
Exome Sequencing
5.Risk factors for lymph node metastasis after RARP in high-risk prostate cancer patients and construction of a nomogram
Qi CAI ; Ziyan AN ; Zhoujie YE ; Jinpeng SHAO ; Kaipeng BI ; Zheng WANG ; Guanqiu CHEN ; Jie ZHU ; Guangfu CHEN ; Shaoxi NIU ; Baojun WANG ; Xin MA ; Jiangping GAO ; Weijun FU
Chinese Journal of Urology 2025;46(8):593-599
Objective:This study investigated the independent risk factors for lymph node metastasis(LNM)in high-risk prostate cancer(HRPCa)patients undergoing robot-assisted radical prostatectomy(RARP),and constructed a nomogram model based on clinical data to improve the accuracy and clinical practicality of preoperative prediction of LNM.Methods:A retrospective analysis was conducted on the clinical data of 218 HRPCa patients who received RARP treatment at the First Medical Center of the PLA General Hospital from January 2020 to March 2025 as the modeling group. The age of the modeling group was(66.91±6.94)years old. 75 cases(34.40%)had a history of smoking,and 48 cases(22.02%)had a history of drinking. There were a body mass index(BMI)of 25.55(23.58,27.00)kg/m 2,a total prostate-specific antigen(tPSA)of 20.59(10.42,30.61)ng/ml,a free prostate-specific antigen(fPSA)of 1.87(1.04,3.26)ng/ml,a prostate volume(PV)of(41.19±21.00)ml,a prostate-specific antigen density(PSAD)of 0.52(0.30,0.84)ng/ml 2. Among the patients,60 cases(27.52%)had a preoperative biopsy Gleason score >8,and the percentage of positive biopsy cores(PPBC)was 50%(31%,80%). Thirty-one patients(14.22%)were staged clinically as >T 2c. The diagnostic criteria for high-risk prostate cancer(HRPCa)were defined as meeting any one of the following:PSA >20 ng/ml,Gleason score on prostate biopsy ≥8,or clinical stage ≥T 3. Among the 218 patients in the modeling cohort,67 cases(30.73%)met two of the criteria,and 7 cases(3.21%)met all three criteria. All 218 patients underwent RARP,and based on postoperative pathology,they were divided into the LNM group and the non-LNM group. The relationship between the number of diagnostic criteria met and the occurrence of LNM was analyzed. An external validation cohort included 42 HRPCa patients who underwent RARP at the Third,Fifth Medical Centers of the PLA General Hospital between January 2023 and May 2025. Their mean age was(66.79±5.92)years. Eighteen patients(42.86%)had a smoking history,and nine(21.43%)had a history of alcohol consumption. The median BMI was 26.00(23.80,27.13)kg/m 2. The median tPSA level was 17.34(8.97,27.30)ng/ml. The median fPSA was 1.51(0.83,2.52)ng/ml,and the median PV was(35.57 ± 15.25)ml. The median PSAD was 0.57(0.23,0.87)ng/ml 2,and the median PPBC was 58%(36%,71%). Three patients(7.14%)had a clinical stage >T 2c,and 12 patients(28.57%)had a Gleason score >8 on preoperative biopsy. Univariate and multivariate binary logistic regression analyses were used to identify independent risk factors for LNM,and a nomogram model was constructed based on these factors. The predictive performance of the model was evaluated using receiver operating characteristic(ROC)curves and calibration plots,and the model was validated in the external cohort. Result:According to postoperative pathology,45 patients were classified into the LNM group,and 173 into the non-LNM group. The probability of LNM increased proportionally with the number of diagnostic criteria met for HRPCa(meeting two criteria: OR = 4.762,95% CI 2.323-9.761, P < 0.01;meeting three criteria: OR = 10.667,95% CI 2.187-52.025, P=0.003). Binary logistic regression analysis revealed that age( OR=0.913,95% CI 0.859-0.971, P = 0.004),tPSA( OR=1.039,95% CI 1.018-1.061, P<0.01),PPBC( OR = 5.656,95% CI 1.101-29.056, P = 0.038),and clinical T stage(T 2c stage: OR=2.945,95% CI 0.888-9.769, P=0.077;>T 2c stage OR = 18.351,95% CI 4.790-70.306, P < 0.01)were independent risk factors for postoperative LNM in HRPCa patients after RARP. The ROC curve of the nomogram model based on these factors showed an area under the curve(AUC)of 0.853(95% CI 0.790-0.917). In the external validation cohort,the nomogram achieved an AUC of 0.743(95% CI 0.556-0.929). The calibration plots demonstrated good agreement between the predicted probabilities and actual observations. Conclusions:Age,tPSA,PPBC,and clinical T stage were independent predictors of postoperative LNM in HRPCa patients undergoing RARP. The greater the number of HRPCa diagnostic criteria met,the higher the likelihood of postoperative LNM. The nomogram developed in this study could effectively predict the risk of LNM in HRPCa patients after RARP.
6.Study on the selection preferences for the community health management service model of older patients with multiple chronic diseases
Xuan-xuan WANG ; Si-yu CAI ; Gang WANG ; Shao-fan CHEN ; Dong-fu QIAN
Chinese Journal of Health Policy 2025;18(3):32-40
Objective:This study was aimed to explore the preference and heterogeneity in community health management service model selection among older patients with multiple chronic diseases,and to provide scientific evidence for optimizing the model.Methods:A multi-stage stratified and convenience sampling approach was adopted.A discrete choice experiment was conducted with 360 elderly patients with multiple chronic diseases from six regions in Jiangsu Province.The Mixed Logit Model was used to analyze service selection preferences and willingness to pay,while the Latent Class Logit Model was applied to explore heterogeneity among patient groups.Results:Patients showed a stronger preference for a service model featuring"twice-monthly visits,medication guidance+lifestyle counseling,and face-to-face consultations,"with willingness to pay values of 170.18 CNY,162.90 CNY,and 112.70 CNY,respectively.Willingness to pay decreased as out-of-pocket costs increased.Heterogeneity analysis identified three distinct preference groups,with statistically significant differences in urban-rural distribution,income levels,and health insurance types.Conclusions and suggestions:Medication and lifestyle guidance are the most valued components of community health management services among older patients with multiple chronic diseases.Patients'demographic and socioeconomic characteristics have a structural influence on their service preferences,highlighting the need to tailor service provision to different population groups.It is recommended to enhance medication guidance capacity at the primary care level,especially in rural areas;promote physical medicine integration to improve the accuracy and effectiveness of lifestyle guidance provided by primary healthcare personnel;strengthen digital infrastructure and streamline service processes to moderately increase the frequency of face-to-face consultations;and improve the integration of medical insurance and public health funding mechanisms to enhance service accessibility and equity.
7.Analysis of clinical phenotypes and genotypic characteristics in children with epilepsy
Yanli JIANG ; Lulu YAN ; Bin FU ; Dongli CAI ; Min XIE ; Xinhua SHAO ; Changshui CHEN ; Shanshan WU ; Haibo LI
Chinese Journal of Medical Genetics 2025;42(9):1045-1052
Objective:To investigate the clinical phenotypes and genetic variant characteristics in children with epilepsy.Methods:A total of 91 children with epilepsy admitted to the Women′s and Children′s Hospital Affiliated to Ningbo University from July 2021 to October 2022 were selected as the study subjects. Peripheral blood samples were collected from the children for whole exome sequencing. Candidate genetic variants were validated by Sanger sequencing and copy number variation sequencing (CNV-seq). The clinical phenotypes and treatment outcomes of the children with epilepsy were followed up, and an analysis of the relationship between genotype and phenotype was conducted. This study was approved by the Women′s and Children′s Hospital Affiliated to Ningbo University (Ethics No.: EC2020-048).Results:Among the 91 children with epilepsy, 21 cases (23.08%, 21/91) were found to carry pathogenic or likely pathogenic variants. Of these, 18 cases had involved single base variant or insertional deletion, while 3 cases involved copy number variations. The gene with the highest detection rate was PRRT2 (38.10%, 8/21). Among the children with genetic variants, 47.62% (10/21) had onset during infancy, with 8 diagnosed with Benign familial infantile epilepsy (BFIE), 8 with Developmental epileptic encephalopathy (DEE), and 3 with Epileptic encephalopathy (EE). One case of Dravet syndrome (DS) and one case of Infantile spasms (IS) were also noted. The clinical manifestations of children were diverse and primarily included generalized tonic-clonic seizures and focal seizures. Among them, 52.38% (11/21) had exhibited cluster seizures, 23.81% (5/21) showed fever sensitivity, and 14.29% (3/21) experienced status epilepticus. After pharmacological treatment, 42.86% (9/21) of children had achieved complete seizure control, while 61.90% (13/21) had intellectual disability and 19.05% (4/21) had co-morbid autism spectrum disorder. Conclusion:Pathogenic or likely pathogenic variants were identified in 23.08% of the pediatric epilepsy cases, with the PRRT2 gene being the most frequently involved. Among children carrying genetic variants, 47.62% had seizure onset during infancy. Genetic factors are an important cause of epilepsy, and early genetic testing may facilitate precise diagnosis, treatment, and prognostic evaluation.
8.Risk factors for lymph node metastasis after RARP in high-risk prostate cancer patients and construction of a nomogram
Qi CAI ; Ziyan AN ; Zhoujie YE ; Jinpeng SHAO ; Kaipeng BI ; Zheng WANG ; Guanqiu CHEN ; Jie ZHU ; Guangfu CHEN ; Shaoxi NIU ; Baojun WANG ; Xin MA ; Jiangping GAO ; Weijun FU
Chinese Journal of Urology 2025;46(8):593-599
Objective:This study investigated the independent risk factors for lymph node metastasis(LNM)in high-risk prostate cancer(HRPCa)patients undergoing robot-assisted radical prostatectomy(RARP),and constructed a nomogram model based on clinical data to improve the accuracy and clinical practicality of preoperative prediction of LNM.Methods:A retrospective analysis was conducted on the clinical data of 218 HRPCa patients who received RARP treatment at the First Medical Center of the PLA General Hospital from January 2020 to March 2025 as the modeling group. The age of the modeling group was(66.91±6.94)years old. 75 cases(34.40%)had a history of smoking,and 48 cases(22.02%)had a history of drinking. There were a body mass index(BMI)of 25.55(23.58,27.00)kg/m 2,a total prostate-specific antigen(tPSA)of 20.59(10.42,30.61)ng/ml,a free prostate-specific antigen(fPSA)of 1.87(1.04,3.26)ng/ml,a prostate volume(PV)of(41.19±21.00)ml,a prostate-specific antigen density(PSAD)of 0.52(0.30,0.84)ng/ml 2. Among the patients,60 cases(27.52%)had a preoperative biopsy Gleason score >8,and the percentage of positive biopsy cores(PPBC)was 50%(31%,80%). Thirty-one patients(14.22%)were staged clinically as >T 2c. The diagnostic criteria for high-risk prostate cancer(HRPCa)were defined as meeting any one of the following:PSA >20 ng/ml,Gleason score on prostate biopsy ≥8,or clinical stage ≥T 3. Among the 218 patients in the modeling cohort,67 cases(30.73%)met two of the criteria,and 7 cases(3.21%)met all three criteria. All 218 patients underwent RARP,and based on postoperative pathology,they were divided into the LNM group and the non-LNM group. The relationship between the number of diagnostic criteria met and the occurrence of LNM was analyzed. An external validation cohort included 42 HRPCa patients who underwent RARP at the Third,Fifth Medical Centers of the PLA General Hospital between January 2023 and May 2025. Their mean age was(66.79±5.92)years. Eighteen patients(42.86%)had a smoking history,and nine(21.43%)had a history of alcohol consumption. The median BMI was 26.00(23.80,27.13)kg/m 2. The median tPSA level was 17.34(8.97,27.30)ng/ml. The median fPSA was 1.51(0.83,2.52)ng/ml,and the median PV was(35.57 ± 15.25)ml. The median PSAD was 0.57(0.23,0.87)ng/ml 2,and the median PPBC was 58%(36%,71%). Three patients(7.14%)had a clinical stage >T 2c,and 12 patients(28.57%)had a Gleason score >8 on preoperative biopsy. Univariate and multivariate binary logistic regression analyses were used to identify independent risk factors for LNM,and a nomogram model was constructed based on these factors. The predictive performance of the model was evaluated using receiver operating characteristic(ROC)curves and calibration plots,and the model was validated in the external cohort. Result:According to postoperative pathology,45 patients were classified into the LNM group,and 173 into the non-LNM group. The probability of LNM increased proportionally with the number of diagnostic criteria met for HRPCa(meeting two criteria: OR = 4.762,95% CI 2.323-9.761, P < 0.01;meeting three criteria: OR = 10.667,95% CI 2.187-52.025, P=0.003). Binary logistic regression analysis revealed that age( OR=0.913,95% CI 0.859-0.971, P = 0.004),tPSA( OR=1.039,95% CI 1.018-1.061, P<0.01),PPBC( OR = 5.656,95% CI 1.101-29.056, P = 0.038),and clinical T stage(T 2c stage: OR=2.945,95% CI 0.888-9.769, P=0.077;>T 2c stage OR = 18.351,95% CI 4.790-70.306, P < 0.01)were independent risk factors for postoperative LNM in HRPCa patients after RARP. The ROC curve of the nomogram model based on these factors showed an area under the curve(AUC)of 0.853(95% CI 0.790-0.917). In the external validation cohort,the nomogram achieved an AUC of 0.743(95% CI 0.556-0.929). The calibration plots demonstrated good agreement between the predicted probabilities and actual observations. Conclusions:Age,tPSA,PPBC,and clinical T stage were independent predictors of postoperative LNM in HRPCa patients undergoing RARP. The greater the number of HRPCa diagnostic criteria met,the higher the likelihood of postoperative LNM. The nomogram developed in this study could effectively predict the risk of LNM in HRPCa patients after RARP.
9.Construction of SARS-CoV-2 receptor binding domain molecular probe and its application in the isolation of neutralizing antibodies
WANG Zheng ; REN Li ; YANG Fu-rong ; SHEN Yu-min ; HU Cai-qin ; HAO Yan-ling ; ZHU Biao ; LI Dan ; SHAO Yi-ming
China Tropical Medicine 2023;23(6):590-
Abstract: Objective To construct SARS-CoV-2 receptor binding domain molecular probe for monoclonal memory B cell sorting and obtain RBD specific neutralizing antibodies from peripheral blood mononuclear cells (PBMCs) of COVID-19 convalescents by single-cell sorting. Methods The SARS-CoV-2 RBD sequence was downloaded from GenBank, and the Avi tag and 6-histidine tags were added at the C-terminal. After codon optimization, it was chemically synthesized, cloned into the pDRVI1.0 vector, expressed after transfection of 293F cells, and biotinylated consequently. RBD-specific B cells were sorted out with this probe1 from the PBMCs of convalescents recovered from COVID-19. After B cells were lysed, the variable regions of heavy chain and light chain were amplified, cloned into the antibody expression vector, and transfected into 293F cells to express the antibody. Then the antibody was purified from the supernatant using protein A column and SARS-CoV-2 pseudovirus was used to test their neutralizing activity. Results RBD-Avi probe was produced and successfully biotinylated sequentially with an efficiency of 30%-50%. Western blot analysis revealed that the biotinylated probe was recognized by the antibodies purified from COVID-19 convalescent plasma. Using this probe, 7 and 16 RBD-specific memory B cells were successfully isolated from the PBMCs of two convalescent individuals, accounting for 0.24% and 0.17% of the total cell population, respectively. After amplifying the variable regions of antibody heavy and light chains from the lysed B cells, 7 and 12 pairs of antibody heavy-light chains were obtained. A total of 16 antibodies were expressed in the convalescent individuals, and most of the purified antibodies showed neutralizing activity against the pseudovirus, with IC50 values of 6 antibodies below 1 μg/mL. The IC50 values of XJ-A9 and SCF-F1 against the wild-type pseudovirus were 0.07 μg/mL and 0.35 μg/mL, respectively. Conclusion The SARS-CoV-2 RBD molecular probe constructed in this study has good antigenicity, and the isolated antibodies present neutralizing activity against wild-type SARS-CoV-2 pseudovirus.
10.Incidence and prognosis of olfactory and gustatory dysfunctions related to infection of SARS-CoV-2 Omicron strain: a national multi-center survey of 35 566 population.
Meng Fan LIU ; Rui Xia MA ; Xian Bao CAO ; Hua ZHANG ; Shui Hong ZHOU ; Wei Hong JIANG ; Yan JIANG ; Jing Wu SUN ; Qin Tai YANG ; Xue Zhong LI ; Ya Nan SUN ; Li SHI ; Min WANG ; Xi Cheng SONG ; Fu Quan CHEN ; Xiao Shu ZHANG ; Hong Quan WEI ; Shao Qing YU ; Dong Dong ZHU ; Luo BA ; Zhi Wei CAO ; Xu Ping XIAO ; Xin WEI ; Zhi Hong LIN ; Feng Hong CHEN ; Chun Guang SHAN ; Guang Ke WANG ; Jing YE ; Shen Hong QU ; Chang Qing ZHAO ; Zhen Lin WANG ; Hua Bin LI ; Feng LIU ; Xiao Bo CUI ; Sheng Nan YE ; Zheng LIU ; Yu XU ; Xiao CAI ; Wei HANG ; Ru Xin ZHANG ; Yu Lin ZHAO ; Guo Dong YU ; Guang Gang SHI ; Mei Ping LU ; Yang SHEN ; Yu Tong ZHAO ; Jia Hong PEI ; Shao Bing XIE ; Long Gang YU ; Ye Hai LIU ; Shao wei GU ; Yu Cheng YANG ; Lei CHENG ; Jian Feng LIU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(6):579-588
Objective: This cross-sectional investigation aimed to determine the incidence, clinical characteristics, prognosis, and related risk factors of olfactory and gustatory dysfunctions related to infection with the SARS-CoV-2 Omicron strain in mainland China. Methods: Data of patients with SARS-CoV-2 from December 28, 2022, to February 21, 2023, were collected through online and offline questionnaires from 45 tertiary hospitals and one center for disease control and prevention in mainland China. The questionnaire included demographic information, previous health history, smoking and alcohol drinking, SARS-CoV-2 vaccination, olfactory and gustatory function before and after infection, other symptoms after infection, as well as the duration and improvement of olfactory and gustatory dysfunction. The self-reported olfactory and gustatory functions of patients were evaluated using the Olfactory VAS scale and Gustatory VAS scale. Results: A total of 35 566 valid questionnaires were obtained, revealing a high incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain (67.75%). Females(χ2=367.013, P<0.001) and young people(χ2=120.210, P<0.001) were more likely to develop these dysfunctions. Gender(OR=1.564, 95%CI: 1.487-1.645), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), oral health status (OR=0.881, 95%CI: 0.839-0.926), smoking history (OR=1.152, 95%CI=1.080-1.229), and drinking history (OR=0.854, 95%CI: 0.785-0.928) were correlated with the occurrence of olfactory and taste dysfunctions related to SARS-CoV-2(above P<0.001). 44.62% (4 391/9 840) of the patients who had not recovered their sense of smell and taste also suffered from nasal congestion, runny nose, and 32.62% (3 210/9 840) suffered from dry mouth and sore throat. The improvement of olfactory and taste functions was correlated with the persistence of accompanying symptoms(χ2=10.873, P=0.001). The average score of olfactory and taste VAS scale was 8.41 and 8.51 respectively before SARS-CoV-2 infection, but decreased to3.69 and 4.29 respectively after SARS-CoV-2 infection, and recovered to 5.83and 6.55 respectively at the time of the survey. The median duration of olfactory and gustatory dysfunctions was 15 days and 12 days, respectively, with 0.5% (121/24 096) of patients experiencing these dysfunctions for more than 28 days. The overall self-reported improvement rate of smell and taste dysfunctions was 59.16% (14 256/24 096). Gender(OR=0.893, 95%CI: 0.839-0.951), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), history of head and facial trauma(OR=1.180, 95%CI: 1.036-1.344, P=0.013), nose (OR=1.104, 95%CI: 1.042-1.171, P=0.001) and oral (OR=1.162, 95%CI: 1.096-1.233) health status, smoking history(OR=0.765, 95%CI: 0.709-0.825), and the persistence of accompanying symptoms (OR=0.359, 95%CI: 0.332-0.388) were correlated with the recovery of olfactory and taste dysfunctions related to SARS-CoV-2 (above P<0.001 except for the indicated values). Conclusion: The incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain is high in mainland China, with females and young people more likely to develop these dysfunctions. Active and effective intervention measures may be required for cases that persist for a long time. The recovery of olfactory and taste functions is influenced by several factors, including gender, SARS-CoV-2 vaccination status, history of head and facial trauma, nasal and oral health status, smoking history, and persistence of accompanying symptoms.
Female
;
Humans
;
Adolescent
;
SARS-CoV-2
;
Smell
;
COVID-19/complications*
;
Cross-Sectional Studies
;
COVID-19 Vaccines
;
Incidence
;
Olfaction Disorders/etiology*
;
Taste Disorders/etiology*
;
Prognosis

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